Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2475-2019 — Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassett

U.S. FDA — Device Enforcement · United States · 2019-02-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2475-2019
Date of alert: 2019-02-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alere San Diego, Inc.
Product category: device
Product type: Devices

Reported risk: The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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